Sun.Sep 10, 2023

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Amid another rise in cases, Covid’s new normal has set in

STAT

Among people who are still paying attention to Covid-19 , there’s been a recent surge — not just in viral activity but in the concern once again being paid to Covid. Headlines announce that transmission is surging and hospitalizations for Covid are rising by alarming percentages. There’s debate in some places about whether or not to resume wearing masks.

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FDA’s New RWE Guidance Provides Recommendations for Sponsors Conducting Non-Interventional Real-World Studies and Describes the Potential to Use RWE for Initial Approvals in One Limited Circumstance

FDA Law Blog: Biosimilars

By Mark A. Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program. This finalized a draft guidance issued in December 2021, largely similar in substance.

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STAT+: Crinetics acromegaly drug succeeds in late-stage trial but would face stiff competition if approved

STAT

SAN DIEGO — Crinetics Pharmaceuticals announced on Sunday that its experimental drug for acromegaly, a rare and serious hormonal disorder, succeeded in a late-stage trial, bringing the San Diego biotech a step closer to applying for Food and Drug Administration approval — and entry into a crowded market with blockbuster therapies sold by pharma giants.

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Roche presents five-year survival outcomes for Tecentriq plus chemotherapy in ES-SCLC

Express Pharma

Results presented from the Phase III IMpower133 study and extension trial IMbrella A, show Roche’s Tecentriq (atezolizumab), in combination with chemotherapy, demonstrates a potential long-term overall survival (OS) benefit as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). As presented at the IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer, these are the first reported five-year survival outcomes for peop

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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EMCrit 357 – AMAX4 Crashing Anaphylaxis Explosion with Ben McKenzie

EMCrit Project

The explosion follow-up on the AMAX4 protocol for crashing anaphylaxis and asthma with Ben McKenzie [@amax4] EMCrit Project by Scott Weingart, MD FCCM.

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New patent expiration for Cumberland Pharms drug VIBATIV

Drug Patent Watch

Annual Drug Patent Expirations for VIBATIV Vibativ is a drug marketed by Cumberland Pharms and is included in one NDA. It is available from one supplier. There are two patents… The post New patent expiration for Cumberland Pharms drug VIBATIV appeared first on DrugPatentWatch - Make Better Decisions.

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New patent expiration for Novartis drug TYZEKA

Drug Patent Watch

Annual Drug Patent Expirations for TYZEKA Tyzeka is a drug marketed by Novartis and is included in two NDAs. There are two patents protecting this drug. This drug has eleven… The post New patent expiration for Novartis drug TYZEKA appeared first on DrugPatentWatch - Make Better Decisions.

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Acute Kidney Injury

RX Note

Introduction Acute kidney injury (AKI) refers to the abrupt decrease in kidney function , resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours. Increase in serum creatinine of ≥ 50% from baseline, which is known or presumed to have occurred within the prior 7 days, or Fall in urine output to 6 consecutive hours in adults and >8 hou

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New patent for Taiho Oncology drug LONSURF

Drug Patent Watch

Annual Drug Patent Expirations for LONSURF Lonsurf is a drug marketed by Taiho Oncology and is included in one NDA. It is available from one supplier. There are six patents… The post New patent for Taiho Oncology drug LONSURF appeared first on DrugPatentWatch - Make Better Decisions.

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Chronic Kidney Disease

RX Note

Introduction The kidneys are responsible for the following functions: Regulation of fluid volume, osmolarity, blood pressure, electrolyte concentrations and acidity Excretion of metabolic end products and foreign substances such as urea, toxins and drugs Synthesis of renin, erythropoietin and calcitriol Assessing kidney function is an important skill not only for determining the appropriateness of drug dosages but to help with ongoing monitoring and management of kidney disease.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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As Cheap As Amazon Will Let Me! PTCB Crossword Puzzle Book!

Med Ed 101

The Enjoyable Way To Study For The PTCB Exam! Introducing our new PTCB Crossword Puzzle Book! Great gift for any pharmacy technician or aspiring pharmacy student! We are excited to release a brand new book for our pharmacy technician friends! This will be priced as cheap as Amazon will let me for a short period […] The post As Cheap As Amazon Will Let Me!

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A Heartfelt Solution: Camzyos

PharmExec

First-of-its-kind treatment offers hope in the fight against rare heart disease.

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Which pharmaceutical companies have the most SPCs in Sweden?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Sweden. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating… The post Which pharmaceutical companies have the most SPCs in Sweden? appeared first on DrugPatentWatch - Make Better Decisions.